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Nebulized formoterol provides added benefits to tiotropium treatment in chronic obstructive pulmonary disease.
Adv Ther. 2009 Nov; 26(11):1024-34.AT

Abstract

INTRODUCTION

The use of one or more long-acting bronchodilators is key in the maintenance therapy of chronic obstructive pulmonary disease (COPD). This analysis pooled the results of two double-blind studies evaluating the efficacy and safety of adding nebulized formoterol fumarate inhalation solution (FFIS) to maintenance tiotropium (TIO) treatment.

METHODS

Following a run-in period of 7-14 days with once-daily TIO 18 microg, COPD subjects (> or =25% to <65% predicted forced expiratory volume in 1 second [FEV(1)]) were randomized to twice-daily FFIS 20 microg (n=145) or nebulized placebo (PLA, n=140) while continuing on maintenance TIO for 6 weeks. Efficacy was measured using serial spirometry, transition dyspnea index (TDI), rescue albuterol use, and St. George's Respiratory Questionnaire (SGRQ).

RESULTS

The mean standardized area under the curve for FEV(1) over 3 hours (FEV(1)AUC(0-3)), the primary efficacy variable, was significantly higher in the FFIS/TIO group than the PLA/TIO group on day 1 (140 mL difference, P<0.0001) and week 6 (192 mL difference, P<0.0001). Mean TDI scores in the FFIS/TIO and PLA/TIO groups were 1.97 and 0.67, respectively (P=0.0001). Mean albuterol use declined in the FFIS/TIO group from 2.6 to 1.5 puffs/day compared with little change in the PLA/TIO group (P<0.0001). SGRQ scores were similar between treatment groups with the exception of the symptoms score, which improved in the FFIS/TIO group (-5.8) compared with PLA/TIO (-1.0), and more FFIS/TIO-treated subjects experienced a clinically significant improvement in total SGRQ score. More PLA/TIO-treated subjects than FFIS/TIO-treated subjects experienced adverse events (AEs) (45.7% vs. 31.0%) and COPD exacerbations (7.9% vs. 3.4%).

CONCLUSIONS

The addition of FFIS to maintenance TIO treatment for moderate to severe COPD results in significantly improved FEV(1) and dyspnea, decreased rescue medication use, and a lower incidence of AEs and COPD exacerbations. The addition of FFIS to TIO yields clinically and statistically significant benefits for COPD patients and might be of long-term benefit.

Authors+Show Affiliations

David Geffen School of Medicine at UCLA, Los Angeles, California 90095, USA. dtashkin@mednet.ucla.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19953349

Citation

Tashkin, Donald P., et al. "Nebulized Formoterol Provides Added Benefits to Tiotropium Treatment in Chronic Obstructive Pulmonary Disease." Advances in Therapy, vol. 26, no. 11, 2009, pp. 1024-34.
Tashkin DP, Hanania NA, McGinty J, et al. Nebulized formoterol provides added benefits to tiotropium treatment in chronic obstructive pulmonary disease. Adv Ther. 2009;26(11):1024-34.
Tashkin, D. P., Hanania, N. A., McGinty, J., Denis-Mize, K., & Chaudry, I. (2009). Nebulized formoterol provides added benefits to tiotropium treatment in chronic obstructive pulmonary disease. Advances in Therapy, 26(11), 1024-34. https://doi.org/10.1007/s12325-009-0080-z
Tashkin DP, et al. Nebulized Formoterol Provides Added Benefits to Tiotropium Treatment in Chronic Obstructive Pulmonary Disease. Adv Ther. 2009;26(11):1024-34. PubMed PMID: 19953349.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Nebulized formoterol provides added benefits to tiotropium treatment in chronic obstructive pulmonary disease. AU - Tashkin,Donald P, AU - Hanania,Nicola A, AU - McGinty,Joe, AU - Denis-Mize,Kimberly, AU - Chaudry,Imtiaz, Y1 - 2009/12/02/ PY - 2009/09/29/received PY - 2009/12/3/entrez PY - 2009/12/3/pubmed PY - 2010/3/24/medline SP - 1024 EP - 34 JF - Advances in therapy JO - Adv Ther VL - 26 IS - 11 N2 - INTRODUCTION: The use of one or more long-acting bronchodilators is key in the maintenance therapy of chronic obstructive pulmonary disease (COPD). This analysis pooled the results of two double-blind studies evaluating the efficacy and safety of adding nebulized formoterol fumarate inhalation solution (FFIS) to maintenance tiotropium (TIO) treatment. METHODS: Following a run-in period of 7-14 days with once-daily TIO 18 microg, COPD subjects (> or =25% to <65% predicted forced expiratory volume in 1 second [FEV(1)]) were randomized to twice-daily FFIS 20 microg (n=145) or nebulized placebo (PLA, n=140) while continuing on maintenance TIO for 6 weeks. Efficacy was measured using serial spirometry, transition dyspnea index (TDI), rescue albuterol use, and St. George's Respiratory Questionnaire (SGRQ). RESULTS: The mean standardized area under the curve for FEV(1) over 3 hours (FEV(1)AUC(0-3)), the primary efficacy variable, was significantly higher in the FFIS/TIO group than the PLA/TIO group on day 1 (140 mL difference, P<0.0001) and week 6 (192 mL difference, P<0.0001). Mean TDI scores in the FFIS/TIO and PLA/TIO groups were 1.97 and 0.67, respectively (P=0.0001). Mean albuterol use declined in the FFIS/TIO group from 2.6 to 1.5 puffs/day compared with little change in the PLA/TIO group (P<0.0001). SGRQ scores were similar between treatment groups with the exception of the symptoms score, which improved in the FFIS/TIO group (-5.8) compared with PLA/TIO (-1.0), and more FFIS/TIO-treated subjects experienced a clinically significant improvement in total SGRQ score. More PLA/TIO-treated subjects than FFIS/TIO-treated subjects experienced adverse events (AEs) (45.7% vs. 31.0%) and COPD exacerbations (7.9% vs. 3.4%). CONCLUSIONS: The addition of FFIS to maintenance TIO treatment for moderate to severe COPD results in significantly improved FEV(1) and dyspnea, decreased rescue medication use, and a lower incidence of AEs and COPD exacerbations. The addition of FFIS to TIO yields clinically and statistically significant benefits for COPD patients and might be of long-term benefit. SN - 1865-8652 UR - https://www.unboundmedicine.com/medline/citation/19953349/Nebulized_formoterol_provides_added_benefits_to_tiotropium_treatment_in_chronic_obstructive_pulmonary_disease_ L2 - https://dx.doi.org/10.1007/s12325-009-0080-z DB - PRIME DP - Unbound Medicine ER -